Hypoglycemia, especially, nocturnal hypoglycemia, is not a well-managed disease. Even though hypoglycemic episodes may lead to impaired epinephrine response and diminished neurological function, patients ignore the disease due to the lack of a practical solution on the market and ignorance of the long-term impact on their health. Symptoms of nocturnal hypoglycemia are usually subtle and may include nightmares, morning fatigue, and headache. More serious symptoms, although rare, sometimes appear and include seizures and loss of consciousness.
Unrecognized hypoglycemic episodes are known to occur in 62.5% of type-1 diabetic patients and in 46.6% of type-2 diabetic patients, with the majority (73.7%) of all events occurring at night. It has been shown that a very high incidence of nocturnal asymptomatic hypoglycemic episodes occur in type-2 diabetic subjects treated with oral agents. Research has shown that most nocturnal hypoglycemic episodes happen around 4 am, and last longer than hypoglycemic episodes that occur at other times, with a medium duration of 3 hours.
Prominent products on the market, such as GLUCERNA™ shakes or bars, claim to maintain glucose level for a maximum of 3 to 4 hours. Other efforts, such as U.S. Patent Application US2012/0015039, apply controlled-release technology for carbohydrates and other nutrients for sustainable delivery for only about 3 hours in order to enhance athletic performance, increase eye-hand coordination and maintain concentration on the task at hand. Similar efforts can be found in U.S. Pat. Nos. 7,943,163; 6,534,487; 5,576,306; 6,905,702; 6,316,427; 5,776,887; EP06747611; and WO2009/051786 which are hereby incorporated by reference.
U.S. Pat. No. 6,815,436 describes making granules of cornstarch for controlled enzymatic breakdown of amylose and amylopectin. Similarly, U.S. Pat. No. 6,316,427 describes using an uncooked cornstarch product for bedtime ingestion to slowly release carbohydrates. U.S. Pat. No. 5,776,887 describes a diabetic nutritional product for controlled absorption of carbohydrates by delivering “a rapidly absorbed fraction such as glucose or sucrose, a moderately absorbed fraction such as certain cooked starches or fructose, and a slowly absorbed fraction such as raw corn starch.”
Controlled release of carbohydrates with initial release of sugars and lasting about 3-4 hours has been demonstrated. These efforts, however, come with unnecessary nutrients such as vitamins, minerals (such as sodium), and lipids which might have ill-effects for a sleeping individual. Additionally, the previous efforts have suggested delivering long-chain carbohydrates, which not only deliver an unpleasant fullness in the stomach, but also trigger digestion during sleep, and may disturb enzyme secretion thereby causing obesity in type-1 and -2 diabetes patients. A need exist for a composition that is effective at treating and managing hypoglycemia and especially without the side effects.